Trius has announced positive top-line results from our first Phase 3 clinical trial in acute bacterial skin and skin structure infections, or ABSSSI, for our first product candidate, tedizolid phosphate (TR-701), an IV and orally administered second generation oxazolidinone for the treatment of serious gram-positive infections, including methicillin-resistance Staphylococcus aureus (MRSA).
As a second generation oxazolidinone, tedizolid phosphate is chemically differentiated from, and designed for improved potency, resistance and spectrum of activity over, the first generation of clinically developed oxazolidinones. There is only one approved first generation oxazolidinone, linezolid, which is currently the leading branded antibiotic for serious gram-positive infections, with reported worldwide sales of $1.3 billion in 2011.
In less than four years, tedizolid phosphate has successfully completed a Phase 3 trial trial in patients with acute bacterial skin and skin structure infections (ABSSSI), a Phase 2 trial in patients with complicated skin and skin structure infections (cSSSI) as well as 7 Phase 1 trials. Tedizolid phosphate has been highlighted in over 20 publications and in over 50 poster presentations at key international conferences.
We believe tedizolid phosphate offers a number of important potential advantages over linezolid, including greater potency, once daily dosing, predictable drug exposure, a shorter course of therapy, in vivo bactericidal (i.e., bacterial killing) activity, lower frequency of resistance, activity against linezolid-resistant bacterial strains and an improved safety profile.
Under our tedizolid phosphate clinical program, we plan to develop tedizolid phosphate to treat multiple clinical indications, including ABSSSI and other important indications involving infections of the lung and blood, such as, hospital acquired pneumonia (HAP), ventilator acquired pneumonia (VAP) and bacteremia.
Acute bacterial skin and skin structure infections (ABSSSI), a new FDA classification for complicated skin and skin structure infections (cSSSI), are a significant and growing problem throughout the world.
ABSSSI are infections that involve deeper tissue or require surgical intervention (e.g. cellulitis, major cutaneous abscesses, and infected wounds) or are associated with a significant underlying disease (e.g., diabetes or systemic immunosuppression) that complicates response to therapy. A variety of pathogens may be identified in ABSSSI but the two most common Gram-positive pathogens are Staphylococcus aureus and Streptococcus pyogenes. The significant increase in the incidence of MRSA in community as well as hospital acquired infections has resulted in a need for therapy of ABSSSI that is effective against MRSA.